BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHLORAPREP UNKNOWN

    MDR report key: 13423339 · Received February 2, 2022

    Report

    Report Number
    3004932373-2022-00026
    Event Type
    Injury
    Date Received
    February 2, 2022
    Date of Event
    January 19, 2022
    Report Date
    February 15, 2022
    Manufacturer
    CAREFUSION 213, LLC 0113
    Product Code
    OJU
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PR (B)(4) INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4).

    Additional Manufacturer Narrative · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED BY THE MHRA UK. PRIMEVIGILANCE DID REACH OUT TO OBTAIN MORE INFORMATION WITH NO SUCCESS. SHOULD ADDITIONAL INFORMATION BE AVAILABLE IN THE FUTURE, THE COMPLAINT WILL BE RE-OPENED AND INVESTIGATED. ALL COMPLAINTS ARE REVIEWED DURING MONTHLY QUALITY/SAFETY MEETINGS. IN ADDITION, COMPLAINTS ARE TRENDED AT MONTHLY QUALITY DATA ANALYST MEETINGS AND QUARTERLY PLANT MANAGEMENT REVIEW MEETINGS. H3 OTHER TEXT : SEE NARRATIVE BELOW.

    Description of Event or Problem · 0

    IT WAS REPORTED - ADMINISTRATION SITE RASH. VERBATIM: ¿ADMINISTRATION SITE RASH.¿ SUN (B)(6) 2022 1:52 PM. THE ASSOCIATED MIQ NUMBER IS MIQ-01232022-2016. PLEASE FIND ATTACHED SOURCE DOCUMENT DOWNLOADED FROM MHRA ON 19-JAN-2022, WITH LRD: 18-JAN-2022. PLEASE KINDLY NOTE THAT ASSIGNED PV ID NUMBER IS GB-BD-22-000022.

    Description of Event or Problem · 0

    IT WAS REPORTED - ADMINISTRATION SITE RASH VERBATIM: ¿ADMINISTRATION SITE RASH¿. SUN (B)(6) 2022 1:52 PM, THE ASSOCIATED MIQ NUMBER IS (B)(4). PLEASE FIND ATTACHED SOURCE DOCUMENT DOWNLOADED FROM MHRA ON (B)(6) 2022, WITH LRD: (B)(6) 2022. PLEASE KINDLY NOTE THAT ASSIGNED PV ID NUMBER IS (B)(6). THU 2/10/2022 6:19 AM, PLEASE FIND ATTACHED FINAL CIOMS I FOR THE NON-SERIOUS CASE (B)(6) (BD ID: (B)(4)). KINDLY NOTE THAT THE CASE WAS SUBMITTED TO INDIA TODAY, ON (B)(6) 2022 (DUE DATE: (B)(6) 2022). ON AN UNKNOWN DATE, THE PATIENT WAS PREPPED WITH CHLORAPREP (CHLORHEXIDINE GLUCONATE, ISOPROPYL ALCOHOL) FOR AN ILL-DEFINED DISORDER. THE LOT NUMBER, BD CATALOG NUMBER AND PRODUCT EXPIRATION DATE WERE NOT PROVIDED. ON AN UNKNOWN DATE, THE PATIENT DEVELOPED AN ADMINISTRATION SITE RASH. AT THE TIME OF THE REPORT, ACTION TAKEN WITH CHLORAPREP WAS UNKNOWN AND THE EVENT OF ADMINISTRATION SITE RASH RESOLVED. THE REPORTER DID NOT PROVIDE A SERIOUSNESS AND CAUSALITY ASSESSMENT FOR THE REPORTED EVENT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1561823 CHLORAPREP UNKNOWN 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL OJU CAREFUSION 213, LLC 0113 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other